125 matches.
- EventsProfs and Pints DC: The New Politics of Public Health2 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
- Media CoverageJames Boiani Quoted in “Supplement Makers Try to Latch On to GLP-1 Boom”2 minute read
- EventsLondon Healthcare Conference: The Year of Elections - Impact for Life Sciences Operations Across US, EU, and UK1 minute read
- Media CoverageFeatured in Law360: Epstein Becker Green Adds Research Compliance Pro Elizabeth McEvoy2 minute read
- Firm AnnouncementsEpstein Becker Green Welcomes High-Stakes Research Misconduct Attorney and Litigator Elizabeth J. McEvoy, Improves Bench Amid Federal Enforcement Surge3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2025 Promotions4 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Regulatory, Industry, and Legal Perspectives on the Future of the DSCSA3 minute read
- EventsSupplySide West: Ingredient Claims and Legal Flames - an Interactive Workshop to Dodge Regulatory Heat1 minute read
- BlogsExemptions from the Drug Supply Chain Security Act Enhanced Drug Distribution Security Requirements7 minute read
- EventsDiabetes Technology Meeting: Who Can Sell Your Data - a United States Perspective1 minute read
- EventsCombination Products Summit: Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)1 minute read
- Media CoverageMarylana Saadeh Helou Quoted in “FDA Offers Road Map for Remote Trials, but Questions Linger”2 minute read
- EventsRAPS Convergence: Cross-Industry Insights - Leveraging AI to Elevate NextGen Regulatory1 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- Media CoverageChristopher Smith Quoted in “HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA”5 minute read
- EventsHDA 2024 Traceability Seminar: Legal Perspectives for DSCSA Compliance Teams1 minute read
- PublicationsSumming Up the FDA's Long-Anticipated Draft Guidance on Diversity Action Plans3 minute read
- EventsNACDS Total Store Expo: The DSCSA and Chain Drug Stores - Recent Developments and the Future1 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
- The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
- EventsAdolescent Meningococcal Vaccines: Impact and Potential Changes1 minute read
- BlogsPodcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care2 minute read
- Media CoverageStuart Gerson Quoted in “FDA’s Lab Developed Test Rule Could Be First Check on Agency’s Power Post-Chevron”3 minute read
- EventsMultipurpose Prevention Technology (MPT) Summit: Experiences from Other Fields to Help Address MPT Roadblocks1 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 minute read
- BlogsPodcast: If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care2 minute read
- If Cannabis Is Reclassified, What Will Happen to the Marketplace?
- EventsUnpacking the Legal Challenges in Sourcing AI in Health Care and Life Sciences in the US and the EUJune 17 and 21, 202410 minute read
- EventsCIRS: Vaccines for Adults – Increasing Access and Uptake1 minute read
- BlogsFDA Wins Mifepristone Case, NLRB Denied Lower Injunctive Relief Standards, and “Trump Too Small” Denied Trademark - SCOTUS Today7 minute read
- Media CoverageBradley Merrill Thompson Cited in “AI Regulation: Global Picture Balances Innovation and Insight”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Experts Advise Against Prescriptive FDA Policies for Regulating AI”3 minute read
- BlogsNuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading5 minute read
- Media CoverageRachel Snyder Good Quoted in “A First in State AI Law”2 minute read
- EventsBCBS Association: The World of Emerging Therapies and Alternative Substances in Healthcare2 minute read
- BlogsLitigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast41 minute read
- Litigating Nutrition: Class Action Battles Over Dietary Supplements
- FDA Releases Laboratory-Developed Tests Final Rule
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- BlogsFederal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?7 minute read
- Media CoverageKate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct”1 minute read
- EventsABA 2024 HIV Law & Practice Conference: HIV Healthcare – Developments and Possibilities1 minute read
- Events2024 NCICP: Legal Landscape for Vaccination1 minute read
- Media CoverageTheodora McCormick Quoted in “‘Vague’ NY Law Looms for the Vitamin Shoppe, Other Supplement Retailers”3 minute read
- Media CoverageTeddy McCormick Quoted in “NPA to Seek Injunction Against NY Law Related to Weight Loss Supplements”4 minute read
- EventsFDLI Food and Dietary Supplement Safety and Regulation: Dietary Supplement Regulatory Updates – Focus on Agency Enforcement1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Protests FDA Plan to Clear Guidance Backlog by Skipping Comments”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read
- Media CoverageJames Boiani Quoted in “$42M Rat-Infestation Fine Underscores Sanitation Risks Facing Warehouses”3 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- EventsAHLA: Advising Providers – Legal Strategies for AMCs, Physicians, and HospitalsFebruary 5–7, 20242 minute read
- Media CoverageBradley Merrill Thompson Discusses “Problematic Guidance Patterns Remain at FDA”2 minute read
- EventsCurrent Developments in Digital Health Technology and Regulation: More Than Medical Devices - Development and Use of Companion Apps for Pharmaceutical Products and Beyond1 minute read
- EventsFundamentals of Digital Health Regulation: What Advertising and Promotion Requirements Apply?1 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved”2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Publications9th Circ. Scienter Ruling May Strengthen FDA's Leverage1 minute read
- EventsWorld Vaccine Congress West Coast: How Are NITAGs & HTAs Thinking About Novel Antibody Products?1 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom”2 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Drug Supply Chain Security Act Changes and Implications for Dispensers2 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- Events11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements: Class Action Boot Camp2 minute read
- Post-Dobbs: One Year Later
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 minute read
- PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- The Legal Battle Over Mifepristone
- Direct Access Laboratory Testing: Physician Orders and Specimen Collection
- Legal and Regulatory Landscape for Psychedelics as Therapies
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New Submissions”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance for AI Change Control Shifts Workload to Initial Premarket Filing”1 minute read
- Media CoverageJames Boiani Quoted in “The Hazy Future of the VALID Act”2 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ Concept”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read
- EventsMachine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy, and Security Risks1 minute read
- Direct Access Laboratory Testing: Reimbursement & Compliance
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down Without a Fight”2 minute read
- Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- EventsAdvanced Topics in Clinical Research2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated”2 minute read
- Media CoverageBradley Merrill Thompson Featured in BioWorld: Discussion of FDA Guidance for CDS Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Guidance Hikes Oversight of Clinical Decision Support Software”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority”2 minute read
- Media CoverageMagic Mushrooms in the Garden State? A Look into the Proposed Psilocybin Legal Landscape in New Jersey2 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
- EventsNWABR Hybrid IRB Conference: Privacy Pile-Up—Making Sense of Multiple Frameworks for Research Participant Privacy and Data ProtectionJuly 28, 20221 minute read
- EventsFDLI: Legal and Regulatory Opportunities to Address Bias and Transparency in Artificial Intelligence/Machine Learning in Medical DevicesJune 14, 20221 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”4 minute read
- EventsAHLA Academic Medical Centers and Teaching Hospitals Law Institute 2022: Precision Medicine Studies—A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and ResearchFebruary 2, 20222 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- PublicationsFDA's Ingredient Advisory List Raises Due Process Concerns2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Biden Nominates Robert Califf to Return as FDA Head”2 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old Policy”4 minute read
- Firm AnnouncementsEpstein Becker Green’s Commitment to Focused Excellence in Core Practices Extolled in 2022 U.S. News – Best Lawyers “Best Law Firms” Survey5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future”4 minute read
- Media CoverageJames Boiani Quoted in “FDA Has Broad Regulatory Options for Mixing Covid Boosters”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”2 minute read
- Media CoverageJames Boiani Quoted in “Covid Test Makers Told to Update Labeling in Wake of Mutations”2 minute read